Lymph node metastases in stations 8a (common hepatic artery), 9 (celiac trunk) and/or 16b1 (aorto-caval) should lead to abandoning of pancreatoduodenectomy
ID
Bron
Verkorte titel
Aandoening
Pancreatic or periampullary malignancy
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Investigate the effect of lymph node metastases in stations 8a, 9 and 16b1 on overall survival in patients undergoing (classical Whipple or pylorus preserving) pancreatoduodenectomy for pancreatic or peri-ampullary cancer.
Achtergrond van het onderzoek
Pancreatic cancer carries a poor prognosis. Even after surgical resection median survival is only 16-20 months. Improved patient selection may prevent unnecessary major surgery. Several series have advocated routine sampling of lymph nodes during exploration for pancreatoduodenectomy. It is currently uncertain whether lymph node metastases in stations 8a (common hepatic artery), 9 (celiac trunk) and/or 16b1 (aorto-caval) should lead to abandoning of pancreatoduodenectomy, especially in the era of more potent chemotherapy regimens such as FOLFIRINOX. No multicenter prospective study has routinely sampled all these stations.
Doel van het onderzoek
Lymph node metastases in stations 8a (common hepatic artery), 9 (celiac trunk) and/or 16b1 (aorto-caval) should lead to abandoning of pancreatoduodenectomy
Onderzoeksopzet
2015: Start PANODE
2015-2019: Inclusion and data collection via the Dutch Pancreatic Cancer Audit
2020: End of study
Onderzoeksproduct en/of interventie
Standard resection and marking of lymph node stations 8a, 9 and 16b1 during resection of pancreatic or peri-ampullary cancer with pancreatoduodenectomy. Each center can follow routine practice and sampling.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Adult patients (> 18 yrs)
- Pancreatoduodenectomy (either classic Whipple or pylorus preserving) for suspected pancreatic or periampullary malignancy
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Other active malignancy or previous history of any malignancy if not treated with curative intent >5 years previously
- Pregnancy
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8424 |
| Ander register | METc AMC : 015.0124 |